The FDA did not tell them to do a larger trial. They just rejected Ampligen. Desperate people who have resources are importing the drug from Canada -- there are a few U.S. doctors who are willing to use it.

There is NO drug approved for ME/CFS now. Ampligen does help some people with CFS. There were no serious safety concerns.

Yet this drug, which definitely did help certain patients, was not approved, despite its good safety profile. If it helped a subset of desperate patients, why not let them try it to see if it helps? I know someone who took it, but felt that the improvement was so minor as not to be worth continuing. He was unlucky, but some other patients who he met did improve very significantly.

Meanwhile, the FDA approved Aduhelm, which caused brain bleeds and death in Alzheimer's patients, with no proven long-term benefit.

I have no faith in the FDA's process.